Colorectal surgery in Italy: a snapshot from the iCral study group

Abstract

During a recent prospective trial on early diagnosis of anastomotic leakage (AL) after colorectal surgery, we gathered a large database on more than 1500 procedures performed in 19 surgical centers in Italy over a 12-month period. Main purpose of the present paper is to show the epidemiological data about colorectal procedures and anastomotic leakage. Prospective enrollment for all elective colorectal resections with anastomosis (September 2017–September 2018). Primary endpoint was AL; secondary endpoints were morbidity and mortality rates, readmission and reoperation rates, and length of post-operative hospital stay (ClinicalTrials.gov; Identifier: NCT03560180). There were 1546 enrolled cases (56.9% of 2717 total resected cases). The rate of minimally invasive resections was 83.5%. Overall AL rate was 4.92% (76 cases; range per center 0-12.12%). Mean ± SD time to AL diagnosis was 5.95 ± 4.78 days (median 5, range 1-31). Overall morbidity rate was 30.20%, mortality 1.29% (20 cases; range per center 0-3.27), readmission 0.90%, and reoperation 6.92%. Mean ± SD post-operative LOS was 7.89 ± 5.97 days (median 6; range 1-120). AL significantly influenced all other secondary endpoints. This study offers a good snapshot of colorectal resections in Italy. There was a high rate of laparoscopic resections, reflecting the special interest in this kind of surgery by the participating centers. AL, morbidity, mortality, readmission and reoperation rates are compared to those reported in previous population-based studies. Compared to series dealing with open colorectal resections, the time to diagnosis of AL was shortened by several days.

Funding

This research received no specific grant from any funding agency in the public, commercial or not-for-profit sectors. Medtronic SI® Italy gave liberal and unconditioned economic support for the organization of the first, second and third investigator meetings, held in Milan, Italy, on September 2017 and June 2018, and in Rome on October 2018, respectively.

Compliance with ethical standards

Conflicts of interest

The authors have no competing interests to declare.

Ethical approval

The ethics committee of the “Comitato Etico Regionale delle Marche—C.E.R.M.” reviewed and approved this study protocol on September 7, 2017 (protocol no. 2017-0244-AS). All the participating centers submitted the protocol and obtained authorization from the local institutional review board. After completion of the full study report, anonymized participant-level datasets will be available upon reasonable request by contacting the principal investigator.

Informed consent

Informed consent was obtained (in written form) by all the participants in the study.

Publisher's Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Dindo D, Demartines N, Clavien PA (2004) Classification of surgical complications. A new proposal with evaluation in a cohort of 6336 patients and results of a survey. Ann Surg 240:205–213CrossRefGoogle Scholar